Substance evaluation aims to clarify any grounds for considering that a given substance constitutes a risk to human health or the environment. It is a process of data collection and data review, starting with the initial concern and ending with a decision on how to address it, if appropriate. The coordination of this process falls under the responsibility of the European Chemicals Agency (ECHA). Member State competent authorities1 (MS-CAs) are responsible for carrying out the evaluations.

Substances to be evaluated

The Agency in cooperation with Member States (MS) develops criteria for prioritising which substances should be fed into the substance evaluation process. Prioritisation does not only focus on substances but also on break-down products and takes into account suspicion based on structural similarities with other substances of concern or on the outcome of evaluation of similar substances.
The Agency combines information from registration dossiers and dossier evaluation2 (when available) with the prioritising criteria to compile a draft Community rolling action plan which covers a period of three years and specifies substances to be evaluated each year. ECHA submits the first draft rolling action plan to the Member States by 1 December 2011 and adopts the final Community rolling action plan on the basis of an opinion from the Member State Committee3. ECHA publishes it on its website. The Agency will submit draft annual updates to the Member States by 28 February each year.

A Member State may propose a substance for addition to the Community rolling action plan during the process of drafting or at any time, whenever it is in possession of information which suggests that the substance is of priority for evaluation. The Agency decides whether to add this substance to the Community rolling action plan on the basis of an opinion from the Member State Committee. It is not possible to withdraw substances from the Community rolling action plan once it is published.

Only substances that have been registered and appear on the Community rolling action plan will be subject to the process of substance evaluation. The only exception would be when information on the intrinsic properties has been developed with reference to related substances (application of a read-across approach4). Then these related substances may form part of the evaluation. This means that if a registrant has derived some of the data on e.g. substance A by read-across from others (e.g. substances B and C), then these others (B and C) can also be the subject of the evaluation, although substances B and C are not included in the Community rolling action plan and possibly not registered themselves.

Certain substances are exempted from evaluation: substances included in annexe IV of REACH, substances covered by annexe V of REACH and under certain conditions, substances registered, exported and re-imported into the Community, substances registered and recovered. In addition, the provisions of REACH concerning evaluation do not apply to the extent that a substance is used in medicinal products for human or veterinary use and in food or feeding stuff (including use as an additive or as a flavouring). Moreover, evaluation does not apply for the time to polymers. For on-site isolated intermediates used in strictly controlled conditions, which are not subject to evaluation, the MS-CA in whose territory the site is located may however ask for additional information and if necessary recommend any appropriate risk reduction measures; the MS-CA must demonstrate in these cases that use of the substance gives rise to a risk equivalent to the level of concern arising from the use of substances meeting the criteria for possible inclusion in annexe XIV (substances subject to authorisation).

Allocation of substances to Member States

The Community rolling action plan lists the substances to be evaluated each year together with the Member State responsible for the evaluation of the respective substances.
If a substance from the draft Community rolling action plan is not chosen by any Member State, the Agency shall ensure that the substance is evaluated by appointing a MS-CA to carry out the substance evaluation. It is also possible that two or more Member States express an interest in evaluating the same substance. If these Member States cannot agree who should carry out the evaluation, the Agency shall refer the matter to the Member State Committee in order to determine which authority shall be in charge of the evaluation, taking into account the Member State in which the manufacturer(s) or importer(s) is/are located, the respective proportions of total Community gross domestic product, the number of substances already being evaluated by a Member State and the expertise available. If the Member State Committee fails to reach a unanimous agreement, the conflicting opinions are submitted to the Commission, which shall take decision, under the committee procedure, which authority shall be in charge of the evaluation.
If a substance is added to the Community rolling action plan following a notification by a Member State, the proposing MS, or another MS who agrees, shall evaluate that substance.

In carrying out an evaluation of a substance, the competent authorities may appoint another body to act on their behalf, working under the same conditions as them, including the protection of information that has been agreed to be treated as confidential.

Methodology for substance evaluation

The assessment carried out by the MS-CA involves the collection of information relating to the area of concern, the review of this information and a conclusion on whether there is sufficient information to assess the concern.
The main source of information is the registration dossier(s) for the substance. Results from dossier evaluation – if available – or any previous substance evaluation have also to be used. Note that where a MS-CA wants to start a substance evaluation and no compliance check is available, the MS-CA needs to perform a quality check of the dossiers itself.
The evaluating MS-CA may wish to do a targeted substance evaluation, i.e. focus on only specified parts or choose to do a comprehensive evaluation of the substance. In any case, the substance evaluation has to address all grounds that have been identified for considering a risk to human health and/or the environment.

If the evaluating MS-CA comes to the conclusion that, following the data review, the available information is not sufficient to decide whether an initial concern over the risk can be substantiated, it may request further information, including if appropriate, information not required in annexes VII to X of REACH. Any information can be requested, if justifiable, and it may address general aspects, intrinsic properties of the substance and exposure characteristics. The MS-CA may consider engaging in an informal consultation with the registrant(s) to obtain additional information.
If the MS-CA considers that it is better, for whatever reason, not to engage in informal consultation, or if the voluntarily submitted information is still not sufficient to conclude on the concern, the MS-CA may proceed with the drafting of a formal request for further information. Registrant(s) are allowed to comment this draft request and other Member States may propose amendments. Ultimately, a final decision shall be taken by the Agency or the Commission and sent to the registrant(s). The requested information shall be sent to the Agency by the set deadline. After examining any information submitted, the evaluating MS-CA should decide whether the available data are then sufficient to conclude on the concern. If the information is still not sufficient, or the circumstances have changed as a result of the newly submitted data, it shall draft any appropriate decision.

The competent authority shall finish its evaluation activities within 12 months of the start of the evaluation of the substance or within 12 months of the new information being submitted and notify the Agency accordingly. If this deadline is exceeded, the evaluation shall be deemed to be finished.

Outcome of the substance evaluation process

Substance evaluation may lead to conclusions such as:

• initial concern has been removed ;
• action needs to be taken under the restriction or authorisation procedures ;
• there is a need for harmonised classification and labelling ;
• information needs to be given to other authorities to take appropriate action under other legislation.

Moreover the information gained through an evaluation process should be used by registrants to manage the risks related to their substances and to update their registration dossiers.